Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT01429051
Eligibility Criteria:
Inclusion Criteria:
All inclusion criteria were answered 'yes' for a patient to participate in the clinical trial.
* Is the patient a cancer patient with breakthrough Pain (BTP)?
* Has the patient received either oral opioids or transdermal fentanyl for treatment of background pain (BGP) within the last month prior to the screening visit?
* Is the current dose of prescribed opioids (for BGP) equivalent to 60-1000 mg oral morphine/day?
* Has the patient's BGP for the last 7 days prior to the screening visit been generally stable, and on average controlled to a mild level (defined as ≤ 4 on the 11-point Numerical Rating Scale \[NRS\])?
* Does the patient (at the time of the screening visit) experience his/her current BTP episodes to be of such severe pain intensity, that he/she in general needs additional analgesia (i.e. on top of the background opioid treatment)?
* Has the patient on average for the last 7 days prior to the screening visit had at least three BTP episodes per week, but no more than four BTP episodes per day?
* Is the patient able to use intranasal drugs?
* Is the life expectancy of the patient at least 3 months from the date of the screening visit?
Exclusion Criteria:
1. Has the patient had an illicit substance abuse within the last year prior to screening?
2. Does the patient have severe hepatic impairment? - defined as alanine aminotransferase (ALT or) aspartate aminotransferase (AST) levels \> 3x upper limit of normal (ULN)
3. Does the patient have severe renal impairment? - defined as serum creatinine ≥ 3.0 mg/dl (265 micromol/L)
4. Has the patient ever had facial radiotherapy or is the patient scheduled to facial radiotherapy?
5. Has the patient been treated with any monoamine oxidase (MAO) inhibitors within the last 14 days prior to the screening visit?
6. Does the patient have severe impaired respiratory function, which may increase the risk of clinically relevant respiratory depression by BTP fentanyl treatment?
7. Is the patient known to be hypersensitive to fentanyl or to other opioids or any of their excipients?
8. Does the patient have any head injury, primary brain tumor or other pathological conditions, which could significantly increase the risk of increased intracranial pressure or impaired consciousness?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01429051
Study Brief:
Protocol Section:
NCT01429051